Kornimate/medical-research-clean huggingface dataset:
massage, meditation, and tai chi for chronic lower back pain

Conditions: Low Back Pain

Summary: this clinical trial is a preliminary study designed to prepare for a full-scale, randomized clinical trial of the effectiveness of tai chi, mediation, and therapeutic massage for chronic lower back pain in adults.

despite the common use of complementary and alternative therapies for back pain, little is known about how such therapies compare with each other or with conventional medical therapies in terms of effectiveness and cost. this study will lay the groundwork for a full-scale trial that will evaluate the relative effectiveness and costs of three promising relaxation-related techniques (massage, tai chi, and meditation) that are appropriate for both younger and older adults with chronic lower back pain. the pilot study will identify and resolve unanticipated problems and estimate the sample sizes required for an adequately-powered, full-scale trial. participants with chronic lower back pain will be randomly assigned to one of the following groups: tai chi, massage, meditation, or continued usual care (control group). the participants assigned to each intervention will be divided equally between persons under and over age 65.

Eligibility criteria:
inclusion criteria * chronic lower back pain
extension study following the studies mt-1186-a03 or a04 to evaluate the safety of oral edaravone in subjects with als

Conditions: ALS

Summary: the purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. this study will be continued until the earlier date when oral edaravone is commercially available at each site in japan or august 2023.


Eligibility criteria:
inclusion criteria: * subjects must provide a signed and dated informed consent form (icf) to participate in the study. * subjects must be able (in the judgment of the investigator) to understand the nature of the study and all risks involved with participation in the study * subjects must be willing to cooperate and comply with all protocol restrictions and requirements. * subjects who successfully complete week 96 of study mt-1186-a03 or week 48 of study mt-1186-a04 and have been compliant with study drug (80-120%). exclusion criteria: * subjects of childbearing potential unwilling to use a highly effective method of contraception from the visit #1 until 3 months after the last dose of study medication. * subjects who have a significant risk of suicide. subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the c-ssrs at week 96 of the a03 study or at week 48 of the a04 study. * subjects who are not eligible to continue in the study, as judged by the investigator.
dose/response of exercise on long term weight loss

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: to examine the dose-response of exercise on long-term weight loss in overweight adult women.

background: exercise is a key component of behavioral weight loss programs because of its effect on weight loss, body composition, cardiovascular disease risk factors, and other obesity related diseases such as type 2 diabetes mellitus. despite these benefits, it is unclear whether there is an optimal exercise duration and/or intensity that will enhance long-term weight loss. the current public health recommendation for physical activity is for individuals to participate in at least 30 minutes of moderate intensity physical activity on most days of the week (approximately 150 minutes per week total). however, it is unclear whether this amount of exercise is adequate for long-term weight loss. moreover, cross-sectional studies have shown that individuals that have been successful at long-term weight loss participate in levels of physical activity that are greater than the current public health recommendations. design narrative: the researchers hypothesized that adopting higher levels of exercise duration and/or intensity, coupled with a strong behavioral intervention would enhance long-term weight loss. to test this hypothesis, they recruited 200 overweight women and randomly assigned them to one of four treatment groups: (1) moderate intensity, moderate 1000cal/wk duration exercise, (2) vigorous intensity moderate duration exercise, (3) moderate 2000cal/wk intensity, high duration exercise, and (4) vigorous intensity, high duration exercise. all subjects participated in a 24-month behavioral weight loss program, with subjects attending group meetings and receiving periodic telephone contacts from the weight loss program, with subjects attending group meetings and receiving periodic telephone contacts from the interventionists. in addition, to facilitate the adoption of the exercise protocols, all subjects were provided with a home treadmill. assessment of body weight occured at 0, 6, 12, and 24 months and exercise participation was measured throughout the program. in addition, body composition, cardiorespiratory fitness, cardiovascular disease risk factors, and mediators of behavior change were measured at 0, 6, 12, and 24 months. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
correlation between gut microbiota and clinical response to car-t treatment for hematological malignancies

Conditions: Hematological Malignancies; Chimeric Antigen Receptor T-cell Therapy

Summary: the purpose of this prospective and observational study is to evaluate the correlation between gut microbiota and clinical response to car-t treatment for hematological malignancies

chimeric antigen receptor t-cell (car-t) therapy has shown impressive efficacy in hematological malignancies. however, response rates and associated immune-related adverse effects widely vary among patients. and no biomarkers have been identified to predict the efficacy and associated toxicities after car-t therapy in patients. several preclinical experiments and clinical studies have shown that gut microbiota was associated with the efficacy of t cell-driven cancer immunotherapies and their toxicities. in hematologic malignancies, gut microbiota was associated with the development of graft-versus-host disease (gvhd) after allogeneic hematopoietic stem cell transplantation (allo-hsct). however, the potential correlation between gut microbiota and the effificacy and toxicity of car-t therapy is unclear. therefore, in this study, we aim to evaluate the correlation between gut microbiota and clinical response to car-t treatment for hematological malignancies.

Eligibility criteria:
inclusion criteria: 1. age 16-65 years. 2. hematologic malignancies intended for car-t therapy. 3. expected survival time ≥ 3 months (according to investigator's judgement). 4. left ventricular ejection fractions ≥ 55% by echocardiography. 5. alt / ast \<3 times of normal amounts. 6. creatinine\<2.0mg/dl. 7. pt and appt \<2 times of normal amounts. 8. karnofsky performance status ≥ 60. 9. the ecog score ≤2 points. exclusion criteria: 1. pregnant (or lactating) women; 2. uncontrolled active infection； 3. active infection of hepatitis b virus or hepatitis c virus； 4. human immunodeficiency virus (hiv) positive； 5. patients with a history of myocardial infarction or severe arrhythmia within six months or those with class iii or iv cardiac function according to the new york classification； 6. any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Keywords: gut microbiota, car-t
selection of surgical technique in rectal cancer

Conditions: Rectal Neoplasms

Summary: currently, there is no prediction scale available to identify patients with rectal neoplasms as technically complex in the middle and lower thirds; that is, those who are at high risk of affected circumferential margins and low quality of the mesorectum. the application of a predictive model that allows preoperative identification of the group of patients in whom optimal results in mesorectal quality and circumferential margin are less likely to be obtained through laparoscopic or minimally invasive surgery would enable the selection of patients who will require and justify all efforts and healthcare resources to improve surgical outcomes. therefore, the investigators aim to create a predictive model to identify these patients, allowing the discrimination of which patients will benefit from different techniques, or even which ones would be opportune to initially consider an open approach.


Eligibility criteria:
inclusion criteria: * scheduled surgery for anterior resection of the rectum meeting oncological criteria with mesorectal excision. * age ≥ 18 years. * histology of adenocarcinoma with or without neoadjuvant chemotherapy or chemoradiotherapy. * initial stage t1-t4a. any n. any m. * intention for r0 resection. exclusion criteria: * colorectal tumor with histology different from adenocarcinoma. * synchronous colon tumor. * benign pathology or adenoma. * tis. * t4b or oncological multivisceral resections. * history of neoplastic colorectal surgery or local excision or tamis. * perforated or obstructive rectal neoplasm.

Keywords: rectal cancer surgery minimal invasive surgery oncological outcomes
hypoalgesic effect of median nerve neural mobilization compared to a controlled group

Conditions: Cervicobrachial Neuralgia

Summary: the purpose of these study is to compare the effectivity of the median nerve neural mobilization technique to the complete absence of treatment in a group of patients who suffer cervicobrachial pain.

median nerve neural mobilization (mnnm) is a non invasive physical therapy technique that achieves pain relief through mechanical stimulation of the median nerve and the brachial plexus. it is believed that the hypoalgesic effect offered by the neural tissue mobilization procedure is a consequence of descending nervous system pain modulation activity and an improvement in the distinct biomechanical and sensitive properties of the involved neural tissue. the neural tissue mobilization procedure is associated to an increase in nerve mobility, edema, inflammation and intraneural pressure reduction without any known side effects when applied properly which is an important contrast to the wide variety of side effects caused by commonly used drug therapy to treat cervicobrachial pain. despite the crescent interest among the scientific community in evidence based options to treat pain there is a current lack of enough controlled double blind clinical trials that measure the effectiveness of neural tissue mobilization techniques such as the (mnnm) and its specific effect over cervicobrachial pain. for this reason the present investigation consisted in the application of a treatment protocol based on median nerve neural mobilization in a controlled double blind clinical trial with the aim to assess its clinical effectiveness in treating pain symptoms.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cervicobrachial pain confirmed by magnetic resonance imaging * presence of unilateral symptoms of arm pain, paresthesia or numbness in the upper extremity during at least 3 continuous months previous to the application of treatment. * positive results in all of the following tests: spurling, distraction, and upper limb exclusion criteria: * contraindication in the use of nonsteroidal anti-inflammatory drugs (nsaids) * the use of any type of treatment, therapy, procedure or drug to relieve pain * patients who are under anticonvulsant, antidepressant or psychotropic medication * vertebral instability * vertebral osteoporosis * vertebral or spine infection. * neurologic diseases of genetic, infectious or neoplastic origin * cervical stenosis myelopathy * pregnancy * kinesiophobia * endocrine disorders and menopause * history of spine surgery * intellectual disability, severe mental illness, intoxication, severe sleep deprivation, alzheimer's disease.
hyperbaric oxygen therapy for acute domestic carbon monoxide (co) poisoning

Conditions: Carbon Monoxide Poisoning

Summary: carbon monoxide poisoning still places a burden on the healthcare system worldwide. while oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (hbo) remain controversial. this study aimed at comparing one session of hbo at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.


Eligibility criteria:
inclusion criteria: * patients older than 15 years of age * admitted for domestic co poisoning within 12 hours after the end of co exposure. * had transient loss of consciousness (syncope, malaise) * carboxyhemoglobin level at presentation \>10% or 5%, in smokers and non-smokers, respectively. exclusion criteria: * poisoning by more than one compound (e.g., co plus a drug or co plus other toxic gases such as those found in fire smoke * suicide attempt * pregnancy * coma * contraindications to hbo (circulatory collapse or pneumothorax) * technical obstacles to hbo * non domestic co poisoning * difficulty in determining whether the patient experienced initial loss of consciousness or initial coma * consent refusal.

Keywords: intoxication carbon monoxide adults domestic accident acute domestic carbon monoxide poisoning
assessment of photopill capsule treatment for safety and feasibility in ulcerative proctitis

Conditions: Ulcerative Colitis; Proctitis

Summary: low level light therapy (lllt) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. likewise ibd is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. therefore we hypothesize that lllt might be effective in treating ibd and the photopill capsule was developed for this purpose. an open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the photopill capsule treatment in patients with mild to moderate ulcerative proctitis. primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition. furthermore clinical and biochemical parameters are monitored during the study.


Eligibility criteria:
inclusion criteria: * diagnosed with ulcerative proctitis (mayo grade 1/2) exclusion criteria: * symptomatic hemorrhoids * pregnant or lactating females * patients that have used any experimental treatment within 8 weeks prior to day 0 * patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to day 0 * rectal therapy 2 weeks prior to day 0

Keywords: ulcerative colitis ulcerative proctitis low level light therapy safety efficacy
the effect of electronic cigarette (ecig) liquid vehicles on ecig acute effects

Conditions: Nicotine Exposure; Nicotine Withdrawal Suppression

Summary: this study examines the acute effects in ecig users of the two primary vehicles in ecig liquids, propylene glycol and vegetable glycerin. thirty experienced ecig users will use an ecig in five conditions that will differ only by the propylene glycol:vegetable glycerin ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid nicotine concentration, puff number, and interpuff interval all will be held constant). plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in each condition.

electronic cigarettes (ecigs) are among the most important issues in public health today due to their dramatic increase in popularity. however, very little is known about ecigs, including what factors may make them more likely to be used and abused. examining factors that influence nicotine yield, delivery, and subjective effects from ecigs is essential to understanding their abuse liability. limited pre-clinical research has revealed that nicotine yield may be influenced by the ratio of the two liquid vehicles, propylene glycol (pg) and vegetable glycerin (vg), most commonly found in ecig solutions. specifically, higher proportions of pg result in greater nicotine yields. however, the influence of pg:vg ratio on nicotine delivery and subjective effects associated with ecig use has not been examined previously. the primary hypotheses are that higher proportions of pg will result in greater nicotine delivery and subjective effect profiles suggestive of higher abuse liability in ecig users. results from this project will result in further understanding of the factors that influence the abuse liability of ecigs and could inform regulation of these products.

Eligibility criteria:
inclusion criteria: * participants must use ≥1 ml of ecig solution daily * must use ecig solution with a nicotine concentration ≥12 mg/ml * must have used an ecig for ≥3 months * must be willing to abstain from nicotine and tobacco products for ≥12 hours prior to each session. exclusion criteria: * history of chronic disease or psychiatric condition * regular use of a prescription medication * marijuana use \>10 and alcohol use \>25 days in the past 30 * any other illicit drug use (e.g., cocaine, opioids) in the past 30 days. * positive test for pregnancy (by urinalysis) * daily use of \>5 conventional tobacco cigarettes
bupivicaine to reduce postoperative pain in laparoscopic ventral hernia repair

Conditions: Postoperative Pain

Summary: the investigators are testing to see if infusion of bupivicaine between the mesh and abdominal wall can reduce postoperative pain and decrease use of narcotics in the postoperative setting.

the primary objective of this study is to test different methods for pain management following laparoscopic ventral hernia repair. we hypothesize that local analgesic injection between the abdominal wall and mesh intraoperatively during laparoscopic ventral hernia repair will result in a 20% decrease in the use of post-surgery pain medication in the first four hours after surgery.

Eligibility criteria:
inclusion criteria: 1. patient must be scheduled for a laparoscopic ventral hernia repair at sbch. if any additional procedure is performed, the subject will be excluded from the study 2. age 18 or older 3. patient must agree to complete pain journal postoperatively 4. informed consent signed and dated by patient. consenting through a legally authorized guardian will not be accepted due to the necessity of completing a subjective pain journal exclusion criteria: 1. any surgical procedure occurring besides the study procedure 2. any allergy or sensitivity to bupivicaine or its derivatives 3. less than 18 years of age 4. patient unable to self report in pain journal due to cognitive disabilities 5. discharged less than 4 hours post-surgery
renal protective effect of acei and arb in primary hyperoxaluria

Conditions: Hyperoxaluria

Summary: this study will test the effectiveness of two medications: acei (angiotensin converting enzyme inhibitor)and arb (angiotensin receptor blocker) in reducing the renal injury induced by hyperoxaluria in patients with primary hyperoxaluria. hypothesis: calcium oxalate crystal deposition in the kidney causes inflammation and resulting injury to kidney tissue. angiotensin blockade will improve these changes, thus slowing the progression of renal insufficiency in patients with primary hyperoxaluria.

in patients with primary hyperoxaluria (ph), deficiency of hepatic enzymes important in disposition of glyoxylate results in marked hyperoxaluria. calcium oxalate crystals and high oxalate concentrations in the renal filtrate result in inflammation and injury in the renal parenchyma. loss of renal function over time is characteristic, with end stage renal failure occurring in half the patients by age 35 years, but as early as infancy in some patients. experience in animal models of hyperoxaluria, and from other renal diseases, supports a role for acei and arb medications in ameliorating inflammation and injury thus providing a renal protective effect. we propose to study the short-term effect of combined angiotensin converting enzyme inhibitor (acei) and angiotensin receptor blocking (arb) therapy in patients with ph, in a controlled, randomized, two-year study. primary endpoints will be urinary markers of renal tubular injury (retinol binding protein (rbp), alpha 1 microglobulin (α1m), γ-glutamyl transferase (ggt)) and interstitial fibrosis (transforming growth factor beta 1 (tgfβ1). secondary endpoints will be the rates of change in renal tubular injury and renal function as determined by serum creatinine and creatinine clearance.

Eligibility criteria:
inclusion criteria: 1. diagnosis of ph established by liver enzyme analysis in the patient or an affected sibling, dna testing for mutations of the agxt and gr/hpr gene, or meeting clinical criteria (urine oxalate \> 70 mg/1.73 m2/day in the absence of malabsorption or dietary excess of oxalate. elevated urine glycolate or glycerate provides supporting evidence of type i or type ii ph, respectively). 2. hyperoxaluria that persists during treatment with pyridoxine. 3. ten years of age or older. 4. glomerular filtration rate \> 50 ml/min/1.73 m2 at the start of the study. 5. women of child bearing age will be required to use adequate contraception for 3 months before and throughout the study. 6. patients will be on a stable program of pyridoxine, neutral phosphate, or citrate medications - exclusion criteria: a. age \< 10 years. b. glomerular filtration rate \< 50 at start of study c. hypersensitivity to acei or arb medications d. chronic use of acei or arb medications prior to enrollment e. hyperkalemia f. previous renal transplant g. homozygosity for the g170r mutation of agxt h. unwillingness to use adequate contraception during the study. i. pregnancy -

Keywords: primary hyperoxaluria
enteral nutrition after pancreaticoduodenectomy

Conditions: Cancer of Pancreas; Cancer of Duodenum; Ampulla of Vater Cancer; Cholangiocarcinoma

Summary: pancreaticoduodenectomy (pd) is the treatment of choice for resectable periampullary cancer. pd is still associated with a relatively a high incidence of delayed gastric emptying. and, there are no acknowledged strategies to avoid dge. several feeding strategies have been investigated to cope with this problem. however, there is still no consensus concerning the best nutrition support method after pancreaticoduodenectomy. the purpose of this study is to determine the effect of nutrition support methods on dge after pancreaticoduodenectomy: early enteral nutrition or total parenteral nutrition. patients undergoing pancreatoduodenectomy will be randomized to receive early enteral nutrition (en group), or saline administration (saline group), or oral intake only (natural control). the en group will receive standard enteral diet administered through a nasojejunal tube. enteral nutrition will be started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level. the saline group will receive saline administered through a nasojejunal tube beginning from the 1st postoperative day. oral intake will not be restricted in all three group.


Eligibility criteria:
inclusion criteria: patients underwent selective pancreaticoduodenectomy patients ≥18 years old and ≤80 years old having given written informed consent exclusion criteria: previous gastric resection or intestinal reconstruction preoperative complete parenteral or enteral feeding asa score ≥4 pregnant women severe malnutrition patient who cannot give written informed consent.